Tag: molecular diagnostics

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FDA Clears Roche Respiratory Panel with Expanded Pathogen Coverage

New cobas eplex RP3 panel detects up to 19 respiratory pathogens, including Bordetella pertussis, with results available in under two hours.

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Tempus Receives IVDR Class C Certification for xR RNA Sequencing Assay

Tempus AI’s xR RNA sequencing assay has received EU IVDR Class C certification, enabling continued clinical and biopharma access in the EU for gene fusion detection in solid tumors beyond the 2028 regulatory transition deadline.

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Liquid Biopsy Detects Early Lung Cancer Recurrence Months Before Imaging

A study in The Journal of Molecular Diagnostics found that liquid biopsy tests can detect lung cancer recurrence months before imaging, using ctDNA analysis to monitor relapse risk in early-stage NSCLC patients.

Study Shows Skin Biopsies Can Help Diagnose Mitochondrial Disease

Oct 14, 2026 | Diabetes & Metabolic Diseases, Diagnostic Technologies, Molecular Diagnostics

A multicenter study led by Children’s Hospital Colorado finds that skin biopsy fibroblast assays can help diagnose primary mitochondrial diseases, potentially reducing the need for invasive muscle and liver biopsies.

TissueCypher Identifies Risk of Barrett’s Esophagus Progression Beyond Biopsy Alone

Oct 13, 2026 | Cancer, Histology

Castle Biosciences’ new data presented at ACG 2026 show the TissueCypher test offers objective risk stratification for Barrett’s esophagus progression, providing information beyond standard histopathology.

The Next Era of Diagnostic Stewardship

Oct 13, 2026 | Flu & Respiratory Infections, Molecular Diagnostics, Sponsored

As molecular diagnostics expand what laboratories can detect, laboratories are placing greater emphasis on matching the breadth of testing to the patient and how the results will be used.

Multi-Omic Test Predicts Radiation Therapy Benefit in Early-Stage Breast Cancer, Study Finds

Oct 9, 2026 | Breast

An independent validation study of 426 patients evaluated the assay’s ability to assess 10-year recurrence risk and identify patients more likely to benefit from radiation therapy.

Diagnostic Lab Claim Denials Rose 40% in 2025, Report Finds

Oct 8, 2026 | Lab Management

Diagnostic lab, molecular, and genomics claim denials rose 40% to 11.2% in 2025, driven by insurer automation and more prior authorization rejections, according to XiFin’s 2026 Payor Denial Impact Report.

Federal Directive Spurs R&D Focus on Rapid Diagnostics for Vector-Borne Diseases

Oct 8, 2026 | Emerging & Zoonotic Diseases, Molecular Diagnostics

A new federal directive tasks HHS with launching rapid diagnostic R&D for vector-borne diseases, emphasizing decentralized molecular testing as part of a broader strategy to improve local pathogen surveillance.

10x Genomics, Fred Hutch Launch Cancer Diagnostics Research Collaboration

Oct 7, 2026 | Cancer, Leukemia, Molecular Diagnostics

10x Genomics and Fred Hutchinson Cancer Center have launched a multi-project collaboration to study single cell and spatial profiling for cancer diagnostics, including biomarkers in bladder cancer and residual disease detection in AML.

Cerenome Launches Two CSF Molecular Profiling Tests for CNS Cancers

Oct 7, 2026 | Cancer, Molecular Diagnostics

Cerenome has launched two CSF-based molecular profiling tests for CNS cancers, offering DNA and RNA sequencing panels to evaluate primary, metastatic, and hematologic malignancies in the central nervous system.

Pillar Biosciences Launches 80-Gene NGS Panel for Myeloid Malignancies

Oct 6, 2026 | Cancer, Molecular Diagnostics

Pillar Biosciences has introduced the oncoReveal Myeloid v2 Panel, expanding its NGS assay from 58 to 80 genes and enhancing FLT3-ITD detection while maintaining existing laboratory workflows.

TissueCypher Shifts Care Decisions in Barrett’s Esophagus Study

Oct 5, 2026 | Anatomic Pathology

Castle Biosciences’ TissueCypher test informed management changes in 90% of non-dysplastic Barrett’s esophagus cases in a 30-patient study at Keck Medical Center, according to results published in Foregut.

Haystack MRD Accurately Predicts Colorectal Cancer Recurrence, Study Finds

Oct 5, 2026 | Colorectal

A study found that Quest Diagnostics’ Haystack MRD ctDNA test detected colorectal cancer recurrence with up to 100% specificity, outperforming CEA testing in DYNAMIC trial patient specimens.

Urine Cell-Free RNA Test Detects Bladder Cancer and Predicts Therapy Response

Oct 5, 2026 | Cancer, Urine Analyzers

A Stanford-led study found that Resero Bio’s uRARE-seq urine cfRNA test can non-invasively detect bladder cancer, assess tumor grade, and predict therapy response in 683 patient samples.

Renew Biotechnologies, Mayo Clinic Partner to Evaluate cfDNA Biomarker in Multiple Sclerosis

Oct 1, 2026 | Allergy & Autoimmune, Molecular Diagnostics

Renew Biotechnologies and Mayo Clinic have partnered to evaluate NeuroLens, a cfDNA-based test, for monitoring central nervous system injury and disease progression in multiple sclerosis and related neuroimmunologic conditions.

Roche Launches Newborn Screening Test for Three Severe Genetic Conditions

Sep 30, 2026 | Amplification Technologies

Roche subsidiary TIB MOLBIOL has launched a CE-marked newborn screening kit that simultaneously tests for spinal muscular atrophy, severe combined immunodeficiency, and sickle cell disease in laboratories across Europe.

Abbott Launches SimpleScreen CRC Blood Test for Colorectal Cancer Screening

Sep 30, 2026 | Colorectal

Abbott has launched SimpleScreen CRC, an FDA-approved blood test for colorectal cancer screening in average-risk adults, reporting 81.1% sensitivity and 90.4% specificity in a 48,000-patient study.